wg5 “clinical evidence for performance and safety” meeting_5nov_ppt6_wg5 updates.pdfons, gaurav...

WG5 – “Clinical Evidence for

Performance and Safety”

Chair: Yuwadee Patanawong

Co-Chair: Sumati Randeo

Secretary: Gaurav Verma

AHWP 19th TC Meeting

5 Nov 2015, Bangkok

WG5 Membership & Meeting Updates Total number of WG members: 27

◦ Regulators: 7, Industry: 20

Advisors: 2

◦ Shelly Tang , Martin Devitt (TBC)

Steering Committee Members: 7

◦ Yuwadee Patanawong, Sumati Randeo, Greg LeBlanc, Benny ONS, Gaurav Verma, Asma Zuberi, Mie Ohama

◦ Members of the WG who would like to actively engage in drafting and finalizing the guidance documents can apply for the membership of the steering committee to the Chair and Co-Chair, with their respective areas of interest.

2015 WG5 meetings

◦ There were “Three” face to face meetings organized as follows:

◦ March in Singapore, 26-28 May in Bangkok and 2-5 November in Bangkok

◦ Four Teleconference organized on Quarterly basis

2

Proposed Work Plan 2015 - 17

Proposed Work Plan 2015 -17

4

Work Item 1 ( Framework ) Output Target

1. Re-name WG 5 from “Clinical

Performance & Safety” to

“Clinical Evidence for


2. Nomination of Advisor for the

term 2015-17

3. Reconstitution of the WG 5

Structure

Consensus amongst

WG5 members and

TC

2015 -17

SWOT Analysis of WG 5

Framework

Report to be

submitted to TC

End of term 2015- 17 Work Item 2 (Regulatory Updates) Output Target

Regular review of Global clinical

regulatory updates

Presentation at

WG 5 meeting

Minimum

Quarterly calls and

Face – Face

meeting as and

when decided.

Consolidated annual update Presentation at

annual meeting

AHWP annual

meeting


5

Work Item 3 (Collaboration

& Liaison with TC, WGs &

Global Forums )

Output Target

• Closely co-ordinate and liaise

with AHWP different WGs and

TC

Achieve

convergence on

key concepts,

definitions and

essential principles

TC meetings

• IMDRF Monitor IMDRF

activities and

evaluate the

guidance

documents

Provide periodic

updates to the

WG


6

Work Item 4 (Develop &

Draft Guidance Documents )

Output Target

Identify and draft minimum two

AHWP WG 5 guidance document

annually.

Seek inputs and

build consensus

amongst WG5

members

Seek inputs and

build consensus

amongst AHWP

TC members

Seek approval from

TC

Finalize draft by

WG third

quarter meeting .

Target

Endorsement at

AHWP annual

meeting

Proposed Work Plan 2015 - 17

7

Work Item 5 (Liaise with ISO

14155 TC )

Output Target

Provide comments on the ISO

Revisions as and when amendments

are subjected through the ISO

14155 TC

Review the draft and

prepare

recommendations

As per the

deadlines

provided

Participate in the ISO 14155 TC

annual meetings (June 2015)

Present WG 5

recommendations to

ISO 14155 TC

ISO 14155

TC annual

meetings

Present ISO 14155 TC updates AHWP WG 5 meetings

Qtr

Meetings


8

Work Item 6 (Training) Output Target

Global documents Identify minimum

one Global guidance

document annually

for training

Annual

Trainings dates

will be

determined

during

meetings Work Group documents Training to be

conducted on the

endorsed

documents

Work Plan 2015

Updates & Progress Report

Work Plan 2015 - Updates

10

Work Item 1 (Reconstitution of the WG 5) Output Target &

Status

• Proposed name “Clinical Evidence for


• WG5 restructured as follows:

• Two Advisors nominated are

1. Shelly Tang – IVD Confirmed

2. Martin Devitt – MD (TBC)

New name and

WG 5

restructuring

endorsed by WG

and TC chair

Constituted WG5

Steering

Committee

Framed the

“Ground Rules”

to enhance WG

working

Achieved

WG5 restructured

• Two Advisors nominated are

1. Shelly Tang – IVD Confirmed

2. Martin Devitt – MD (TBC)

Work Plan 2015 - updates

12

Work Item 2 (Regulatory

Updates)

Output Target

& Status

• Present India regulatory updates and

Review of the documents on

Accreditation of Ethics Committee,

Investigators & Clinical Sites

Seek inputs

and comments

from WG

members

Achieved

shared the update with

the group in March

WG call

• Country Updates on Revised

Regulations

Presentation at

the WG 5

meeting in

Bangkok

Achieved

Updates were

presented for India ,

Pakistan and China at

May 2015 Bangkok

meeting.


13

Work Item 3

(Collaboration & Liaison

with TC & Global Forums )

Output Target &

Status

• Closely co-ordinate and

liaise with AHWP different

WGs and TC

Initiated discussion with

AHWP Co Chair & TC

chair and Sectary.

Consensus was build to

develop the glossary of

Key concepts and

definitions TBD in next

TC meeting

Initiated

discussion on

Nov 2nd 2015

• IMDRF Monitor IMDRF activities

and evaluate the guidance

documents

Provided

updates

during WG

meeting on

Nov 2nd 2015


14

Work Item 4

(Develop & Draft

Guidance Documents )

Output Target

• Steering Committee of WG

5 deliberated on the

documents coming out of

GHTF, it was determined

that the GHTF guidance

documents were suitable

to serve as foundation and

will be the key reference

for the AHWP WG5

Guidance Documents

• Same was held for the

analogous IVD documents.

Current work plan was

revised to reflect these

changes and WI 4 segregated

as follows:

1. Clinical Evidence

Definition & Key

Concepts MD

2. Clinical Evidence

Definition & Key

Concepts IVD

3. Clinical Evaluation MD

4. Clinical Evidence -

Scientific Validity

Determination and

Performance evaluation-

IVD

Achieved

Listed 4 documents Draft

Documents sent for

comments which were

deliberated by Steering

Committee. These were

mapped with GHTF & ISO

14155 documents

The documents are

proposed for

endorsement

Conditionally as decided by

Steering Committee and TC

chair that the references,

definitions and common

concepts need to be

converged and aligned with

other Working Groups.

2015 Targets & Steps for Document Endorsement

Bangkok Draft scrubbed and shared with SC – June 15th

SC meets through Conference call & finalizes draft – June 24th

WG 5 Members Comment deadline – July 20th

Comments Consolidated from WG 5 Members – July 22nd

SC Scrubs the draft – July 24th

SC team meets through conference call – July 30th

Draft finalized by WG 5 to be posted for public comments – Aug 14th

Public Comments Deadline – Sept 15th

Public Comments review by SC & volunteers from WG 5 – Sept 21St

SC team meets through conference call – Sept 25th

Scrub the draft to be released to TC – Oct 7th

TC approves for endorsement before annual meeting- Oct 15th

2015 Targets & Steps for Document Endorsement


17

Work Item 5 (Liaise with

ISO 14155 TC )

Output Target

Provide comments on the ISO

Revisions as and when

amendments are subjected

through the ISO 14155 TC

Reviewed three

proposed drafts of

ISO 14155 and

recommendations

submitted

Achieved

Participate in the ISO 14155 TC

annual meetings

Present WG 5

recommendations

Achieved Attended

meeting in June 2015

at Lund Sweden

Present ISO 14155 TC updates • AHWP WG 5

meetings

Achieved

Updates provided

during May 28th and

Nov 2nd meetings


18

Work Item 6

(Training)

Output Target & Status

Global documents Organize a panel

discussion on Clinical

Evaluation

Achieved

Panel discussion

organized at Annual

AHWP Meeting Bangkok

It was decided to organize a session on Clinical during the annual

AHWP Meeting workshop on 3rd Nov 2015.

The panelists shared their experiences from established regulatory

systems and emerging regulatory systems, examples: Health

Canada, Australia TGA , EU (Germany), India and Thailand

PROPOSAL : Online training for WG members who are not able to

attend face to face.

Proposed Work Plan 2016


20

Work Item 1 ( Framework ) Output Target

Initiate SWOT Analysis of WG 5 Framework Report to be

submitted to TC

End of term 205-

2017

Work Item 2 (Regulatory Updates) Output Target

Regular review of Global clinical regulatory

updates

Presentation at WG 5

meeting

Quarterly calls

Work Item 3 (Collaboration & Liaison

with TC & Global Forums )

Output Target

• Proposal for a new Work Instruction for 2016 regarding developing a guidance document on “General Principles of Clinical Investigation Audit & Inspection”

Achieve convergence on key concepts, definitions and essential principles

TBD at TC

meetings

• IMDRF Monitor IMDRF activities

and evaluate the guidance

documents

Provide periodic

updates to the

WG


21

Work Item 4 (Develop &

Draft Guidance

Documents )

Output Target

1. Clinical investigations

2. Post-Market Clinical

Follow-up Studies

TBD and TBC TBD and TBC at TC

meetings


22

Work Item 5 (Standards & Best

Practices)

Output Target Date

• AHWP WG 5 will propose a new WI for 2016 regarding developing a guidance document on “General Principles of Clinical Investigation Audit & Inspection”.

• WG 5 seeks collaboration with ISO 14155 TC to support the development of the Guidance Document

WG 5 chair to

facilitate

approval from

AHWP TC and

AHWP chair for

collaboration

with ISO 14155

at AHWP Annual

TC Meeting

2015

TBD


23

Work Item 6

(Training)

Output Target

Work Group

documents

TBD TBC in next face to face

WG meeting

Training for WG members on *

1. GHTF Clinical Investigation----- Greg

2. GHTF Clinical Performance Studies --- Benny / Shelly (TBC)

3. ISO 14155 wrt Clinical Investigation ---- Ohama Mie

* Subject to approval of the Evidence documents prepared by WG in case

not approved then the training will be on Clinical Evidence .

Thanks